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DIN EN 45502-2-1 VDE 0750-10-1:2004-08
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DIN EN 45502-2-1 VDE 0750-10-1:2004-08
Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers); German version EN 45502-2-1:2003More info
This standard specifies requirements that are applicable to those ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat bradyarrhythmias. The tests that are specified in EN 45502 are type tests, and are to be carried out on samples of a device to show compliance. This standard is also applicable to some non-implantable parts and accessories of the devices. The characteristics of the IMPLANTABLE PULSE GENERATOR or LEAD shall be determined by either theappropriate method detailed in this Part 2-1 or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this Part 2-1 shall apply.
| Author | VDE |
|---|---|
| Editor | VDE |
| Document type | Standard |
| Format | Paper |
| Cancellation date | |
| Confirmation date | |
| expiration_de_validite | |
| ICS | 11.040.40 : Implants for surgery, prosthetics and orthotics
|
| Number of pages | 95 |
| Replace | DIN EN 45502-2-1 (2004-02) |
| Cross references | EN 45502-2-1 (2003-12), IDT |
| Weight(kg.) | 0.2615 |
| Year | 2004 |
| Document history | DIN EN 45502-2-1 (2004-08) |
| Country | Germany |
| Keyword | DIN EN 45502;DIN EN 45502-2;EN 45502;EN 45502-2;EN 45502-2-1;45502 |